CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
MRT5005 +1 moredrug
Likely dose
MRT5005 nebulization; specific dose not stated in published recordAI-extracted
Key inclusion· 5
  • ✓Confirmed diagnosis of CF with two CFTR mutations in Class I or II (genotype confirmed at screening)
  • ✓Chronic sinopulmonary disease and/or gastrointestinal/nutritional abnormalities consistent with CF
  • ✓Clinically stable CF disease as judged by investigator
  • ✓FEV1 ≥50% and ≤90% of predicted normal for age, gender, and height at screening
Key exclusion· 5
  • ✕Acute upper or lower respiratory infection, pulmonary exacerbation, clinically significant hemoptysis, or change in chronic respiratory medications within 28 days prior to dosing
  • ✕Receiving ivacaftor monotherapy (KALYDECO)
  • ✕Receiving triple combination therapy (TRIKAFTA) in Parts A and B only
  • ✕Class III, IV, or V CFTR gene mutation in at least 1 allele

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03375047
NCT03375047Phase 2Completed
CompareCT.gov

A Phase 1/2, Randomized, Double-Blinded, Placebo-Controlled, Combined Single and Multiple Ascending Dose Study Evaluating the Safety, Tolerability, and Biological Activity of MRT5005 Administered by Nebulization to Adult Subjects With Cystic Fibrosis

Sanofi·interventional·Posted Dec 15, 2017·Updated Feb 9, 2026

In Brief

A Phase 2 clinical trial evaluating MRT5005 and Normal saline for Cystic Fibrosis. Completed, enrolled 42 participants across 16 sites.

Detailed Summary

This Phase 1/2, first-in-human study evaluated the safety and tolerability of single and multiple escalating doses of MRT5005 administered by nebulization to the respiratory tract of adult subjects with cystic fibrosis (CF).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedDec 15, 2017
Enrollment StartMay 10, 2018
Primary CompletionMar 15, 2022
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 8.5 years ago

Interventions

MRT5005drug

Nebulization of MRT5005

Normal salinedrug

Normal Saline for Inhalation